Trial document

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DRKS-ID: DRKS00013614

Trial Description

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Title

cENZIAN versus ENZIAN – An observational multicenter study on
the prediction of a preoperative to an intraoperative ENZIAN classification for
endometriosis surgery.

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Trial Acronym

cENZIAN-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The planned number of participants is 900-1000 patients. The study is a pure observational study without risk for the study participants.

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Brief Summary in Scientific Language

This multicenter study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The study is to be classified as a non-interventional method study (classification of the cENZIAN classification as a new diagnostic method without any risk for the study participants). The planned number of participants is 900-1000 patients.

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Organizational Data

DRKS-ID: DRKS00013614
Date of Registration in DRKS: 2017/12/22
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 1002/2017, Ethikkommission des Landes Oberösterreich

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Secondary IDs

[---]*

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Health Condition or Problem studied

ICD10: N80 - Endometriosis

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Interventions/Observational Groups

Arm 1: In patients with a planned endometriosis surgery, the common diagnostic measures are carried out routinely (depending on the use or need: palpation/speculum, ultrasound, MRI or further imaging), regardless of the study. The responsible physician will then fill out the section "cENZIAN" in the questionnaire for each diagnostic measure. At the end of the surgical procedure, the surgeon records his intraoperative impressions under the heading "ENZIAN". This concludes the study participation of the patient.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Diagnostic
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

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Secondary Outcome

[---]*

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Countries of Recruitment

AT: Austria
DE: Germany
CZ: Czech Republic
CH: Switzerland

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Locations of Recruitment

University Medical Center Kepler Universitätsklinikum, Linz
University Medical Center Universitätsklinik für Frauenheilkunde, Bern
University Medical Center Universitätsklinikum Tübingen, Tübingen
Medical Center Landesklinikum Melk, Melk
Medical Center UPMD, Prag
University Medical Center Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe, Münster
Medical Center St.Anna Hospital Herne, Klinik für Frauenheilkunde & Geburtshilfe, Herne
University Medical Center Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden
University Medical Center Medizinische Universität Innsbruck, Department Frauenheilkunde, Universitätsklinik für Gynäkologische Endokrinologie und Reproduktionsmedizin, Innsbruck
Medical Center AGAPLESION MARKUS KRANKENHAUS, Frankfurt, Klinik für Gynäkologie und Geburtshilfe, Frankfurt a.M.
University Medical Center Universitätsklinikum Freiburg, Klinik für Frauenheilkunde, Freiburg
Medical Center Marien Hospital Witten, Frauenklinik, Witten
University Medical Center Universitätsklinikum Ulm, Ulm
University Medical Center Medizinische Hochschule Hannover (MHH), Klinik Frauenheilkunde und Geburtshilfe, Hannover
Medical Center Evangelisches Krankenhaus Bethesda Mönchengladbach, Mönchengladbach
Medical Center St. Johannes Hospital, Dortmund

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/01/16
Target Sample Size: 900
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

• Informed consent to participate in the study after preceding written and verbal information
• Suspected or confirmed endometriosis with planned surgery within 6 months
• Ability to consent
• Age > 18 years

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Exclusion Criteria

Inapplicability of the diagnostic procedures routinely provided for preoperative endometriosis-specific knowledge acquisition (e.g. gynecological examination, ultrasound or other imaging)

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Addresses

Primary Sponsor
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- Kepler Universitätsklinikum
- 4020 Linz
- Austria
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
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- Telephone: +43 5 7680 84 23718
- Fax: [---]*
- E-mail: simon-hermann.enzelsberger at kepleruniklinikum.at
- URL: https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
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Contact for Public Queries
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- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
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- Telephone: +43 5 7680 84 23718
- Fax: [---]*
- E-mail: simon-hermann.enzelsberger at kepleruniklinikum.at
- URL: https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Kepler Universitätsklinikum
- 4020 Linz
- Austria
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Approval of ethics comm. (mandatory for transfer to Studybox): Positives Ethikvotum

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* This entry means the parameter is not applicable or has not been set.